UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019592 |
|---|---|
| Receipt number | R000022339 |
| Scientific Title | Safety of colonoscopic therapy with apixaban switched from warfarin |
| Date of disclosure of the study information | 2015/11/02 |
| Last modified on | 2018/09/05 20:30:21 |
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Basic information
Public title
Safety of colonoscopic therapy with apixaban switched from warfarin
Acronym
Safety of colonoscopic therapy with apixaban
Scientific Title
Safety of colonoscopic therapy with apixaban switched from warfarin
Scientific Title:Acronym
Safety of colonoscopic therapy with apixaban
Region
| Japan |
Condition
Condition
colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Shortening of admission period, cost effectiveness, and postoperative hemorrhage of colonoscopic therapy with apixaban are analyzed.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
admission period and cost
Key secondary outcomes
rate of postoperative hemorrhage
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases with warfarin to chronic atrial fibrillation, to whom we can change apixaban from warfarin
Key exclusion criteria
Cases with renal dysfunction (less than Ccr 15mL/min)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naito Yuji |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
0752515519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohisa Yoshida |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Homepage URL
naohisa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都府立医科大学附属病院(京都府)、市立福知山市民病院(京都府)、綾部市立病院(京都府)、京都九条病院(京都府)、京都北部医療センター(京都府)、松下記念病院(大阪府)、朝日大学村上記念病院(岐阜県)、舞鶴医療センター(京都府)、西陣病院(京都府)、京都第一赤十字病院(京都府)、京都市立病院(京都府)、京都鞍馬口医療センター(京都府)、大津市民病院(滋賀県
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
observation trial
Management information
Registered date
| 2015 | Year | 11 | Month | 02 | Day |
Last modified on
| 2018 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022339
